Impact of a Nutritional Supplement on Bone turnover Markers after 6 Months in Indian Healthy Premenopausal women.

Not Applicable

• Registration Number: CTRI/2017/07/009084
• Lead Sponsor: GlaxoSmithKline Consumer Healthcare GSKCH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 135

Inclusion Criteria

Demonstrates understanding of the study procedures restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form

Female Participants

Good general and mental health with in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination

BMI between 18.0 to 30 Kilograms Per Meter Square) inclusive

Women who understand willing able and likely to comply with all study procedures and restrictions

Exclusion Criteria

Pregnant women or who are intending to become pregnant over the duration of the study, Women who have attained physiological menopause, Women who are breast-feeding Current or regular use of any prescription, over the counter (OTC), vitamin supplements herbal medicine, Treatment with bisphosphonates or other medications known to affect bone, History of metabolic bone disease, hormonal disorders or disturbances, Bone fracture, intolerance or hypersensitivity to the study materials, Lactose intoletrance, Participation in another clinical study, Previous participation in this study, history of alcohol or other substance abuse, Smoker, Currently taking any other health food drinks/beverages or supplements, Women who used medication known to influence bone mass and the use of calcium, vitamin D, and multivitamin supplements on a regular basis were stopped 2 months before the onset of the trial. Ongoing conditions known to cause abnormalities of calcium metabolism or skeletal health, malabsorption syndromes (such as coeliac or Crohnâ??s disease), hyperthyroidism, hyperparathyroidism, hypo- or hypercalcaemia, osteomalacia, Pagetâ??s disease, and diabetes, Fracture in the past 12 months, chronic kidney disease, obesity, Severely anemic , Undertaking excessive exercise Contraceptive injections within the previous year, Known histories of surgeries such as bilateral oophrectomy (surgical removal of ovaries), Diagnosed hypogondal states such as Turner syndrome, Klinfelter syndrome, Kallman ,syndrome, anorexia nervosa, hypothalamic amenorrhea or hyperprolactinemia, Hemotological disorders, Rheumatological and autoimmune disorders, Miscellaneous conditions and diseases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in serum C-telopeptide of type 1 collagen and in the ratio of carboxylated (c-OC) to under-carboxylated Osteocalcin (uc-OC)Timepoint: At 6 months